NCT04968717: 2000HIVTrained

2000HIV Trained Innate Immunity in HIV Elite Controllers

Completed Last updated 27 November 2023

What this trial tests

trial in HIV-1-infection in 109 participants. Completed in 27 October 2021.

Timeline

2 August 2021

Primary endpoint
27 October 2021

27 October 2021

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	109
Start date	2 August 2021
Primary completion	27 October 2021
Estimated completion	27 October 2021
Sites	3 locations across Netherlands

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Some individuals are able to spontaneously control HIV replication, the so-called 'elite controllers' (ECs). ECs are crucial for our understanding of HIV infection. While there is more and more evidence pointing towards a role of the innate immune system in elite control, no research has been performed on the role of innate trained immunity in elite control of HIV.

In this cross-sectional case-control study, we will study this role of trained immunity in HIV elite control by comparing ECs both to a non-HIV-infected first-degree relative, and to HIV patients who are not elite controllers. In addition, we will study whether HIV itself can induce a trained innate immunity phenotype.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trained Immunity in Health and Disease.
   Yao M, Zhou J, Mei J, Gao C, et al · · 2025 · cited 3× · PMID 41211186 · DOI 10.1002/mco2.70461
2. Phenotypic and epigenetic profiles of circulating NK cells in spontaneous HIV-1 controllers.
   Huber A, Groenendijk AL, Navas A, Vadaq N, et al · · 2025 · cited 2× · PMID 41027310 · DOI 10.1016/j.ebiom.2025.105948
3. Targeted plasma proteomics identifies MICA and IL1R1 proteins associated with HIV-1 reservoir size.
   Blaauw MJT, Cristina Dos Santos J, Vadaq N, Trypsteen W, et al · · 2023 · cited 2× · PMID 37091231 · DOI 10.1016/j.isci.2023.106486
4. Enhanced TLR7-induced interferon responses in women living with HIV.
   Huber A, Vadaq N, Groenendijk AL, Rios-Vazquez V, et al · · 2026 · PMID 42093980 · DOI 10.3389/fimmu.2026.1791579
5. Persistent viral control status is associated with enhanced innate immune responses in people with HIV-1.
   C Dos Santos J, Groenendijk AL, Ruijten SDE, Knoll R, et al · · 2026 · PMID 41816294 · DOI 10.1016/j.isci.2026.114807